News

Haermonics is preparing for EN ISO certification

Haermonics is preparing for EN ISO certification for the design and development of systems to flush the thoracic body cavities. ISO 13485 is an International Quality System Standard for Medical Devices.

Commenting on the certification, the Chief Executive Officer of Haermonics says: “Receiving ISO certification is a major milestone in the company’s evolution and serves to distinguish us from other med-tech startup companies, who often think of this step in a later stage of the process. We value the quality aspect of the development process very much and therefore this felt like a natural step for us to take”.

Eva Diephuis, Product Owner en clinical trial coordinator, adds: “Even before we founded Haermonics we already thought of directly working according to the ISO13485 standards. It helps you doing the right thing and documenting every step you take in the development process. For us as a start-up company it is a great way to accelerate our process of delivering the highest quality possible. In the end this quality driven approach will contribute to the CE-marking process of the Haermonics Flush device.

Haermonics wins AXON Innovation for Health Award 2016

The third edition of Innovation for Health took place yesterday in WTC Rotterdam. Wouter Markus of Haermonics is the winner of the AXON Innovation for Health Award 2016 for the best pitch presentation. Haermonics received a voucher of €2.500,- worth consultancy hours from AXON Lawyers, the sponsor of the award.

Jury

The best pitch presentation was selected by the jury out of ten innovation pitches given by entrepreneurs and scientists. The jury consisted of Erik Vollebregt of AXON Lawyers, Dinko Valerio, Anne Portwich of LSP and Matthijs Blokhuis of Noaber Foundation & NextGen Ventures.

Innovation for Health

Innovation for Health is considered as the largest Dutch conference, dedicated to innovations in Life Sciences and Health. The event is filled with inspiring sessions, high-impact innovations and ample networking and partnering opportunities. By bringing together key players and stakeholders across the healthcare & Life Sciences spectrum, and fostering dialogue between research, markets, and policy makers, the event aims to contribute to the future of sustainable healthcare.

Haermonics is the winner of the Investors Forum at the Dutch Life Sciences Conference 2015! Haermonics will be awarded an (inter)national partnering ticket with a total value of EUR 2,500.00.

The Investors Forum is an exciting opportunity for those companies looking for equity capital and/or partnerships with companies and institutes across the life sciences value chain, from biotech, med tech and pharma companies to financiers and universities. The forum offers excellent opportunities to present your company or university to all major Dutch life sciences investors and discuss your business strategy, technology direction and capital raising plan.

Haermonics founders David R Koolbergen and Johan SJ Manshanden will give a duo presentation at the EACTS 2015 at the RAI in Amsterdam on Sunday October 4thduring the session “Update on the results and rationale and design of ongoing clinical trials”. The session is scheduled to be held in the Auditorium between 13:15-16:15. During their presentation, Koolbergen and Manshanden will address the following topics: Retained Blood Syndrome (RBS), Continuous Postoperative Pericardial Flushing (CPPF) as a new clinical working method, pilot study results, preliminary results of two ongoing randomized clinical trials, and future research.

All Haermonics team members will be present at the EACTS 2015 as we are continuing our quest to inspire people and to find partners for future collaborations. You are most welcome to come and say hello, especially when you share our philosophy, would like to support our research project, or have clever advice for us. We would be more than happy to take some time to talk or have an interesting discussion. We hope to see you in Amsterdam at the EACTS 2015!

Before starting up Randomized Clinical Trials (RCT) we performed a Safety & Feasibility study on the CPPF method. In an experimental and highly controlled setting 21 patients underwent the Continuous Pericardial Flushing Method adjacent to their cardiac surgical procedure. Most important conclusions were that the CPPF method was safe and feasible in this experimental setting. No method related complications were observed. In comparison with a historic group of patients, the CPPF patients showed a 30% reduction in blood loss but this finding needs to be confirmed in a RCT. The full article can be read and PDF free download at; http://www.ebiomedicine.com/article/S2352-3964(15)30083-9/abstract.

In the news item “zakendoen met” on BNR nieuwsradio our CMO Dave Koolbergen was interviewed to explain the founding process of Haermonics and the supporting role of NLC Ventures in this process. Roland Zegger, managing partner of NLC, is first explaining what NLC Ventures recently achieved with their successful crowdfunding campaign. Thereafter (at 10:50 minutes), Dave Koolbergen will explain about how his invention lead to the founding of Haermonics BV. The item is in Dutch.

The Netherlands Special Envoy for startups Neelie Kroes visited ACE Venture Lab and met with tech and science startups. Ms. Kroes awarded 4 proof-of-concept grants to the university spin-offs and discussed how to improve the entrepreneurial ecosystem in the Amsterdam universities.

After visiting a number of Dutch cities as part of her Startup Delta tour, Neelie Kroes came to Amsterdam Science Park this Tuesday and met with local entrepreneurs, stakeholders and investors – Alexander Rinnooy Kan, Hubert Deitmers, Hans Amman, Jaap Winter and Boris Velthuijzen van Zanten amongst many others. During her visit Ms. Kroes joined Venture Café organized by ACE Venture Lab and awarded €100,000 proof-of-concept grants to four startups: Caelus (AMC), Haermonics (AMC), Innoseis (Nikhef/VU) and Quantis (UvA, FNWI). These grants will help the startups to validate their technologies, expand their teams and enter the market. Earlier that day Neelie Kroes participated in a round table discussion with eight university startups at ACE Venture Lab.

The startup founders told Ms. Kroes about the obstacles and challenges they face in commercializing their innovations as university spin-offs. While many entrepreneurs endorsed the infrastructure and funding opportunities the universities provide, many startups emphasized the difficulties they experience in requesting the funds and licensing their innovations from Amsterdam universities. After this meeting Neelie Kroes mentioned that there is a lack of transparency in communication between universities and startups and that is why Startup Delta, TTOs and ACE Venture Lab will collaborate to find the way Amsterdam universities can improve their valorization and spin-off activities.

The Haermonics team is visiting the EACTS 2014 in Milan. If you share our philosphy, would like to support the research project or just have a good advice you could come and say hello. We are always more than happy to take some time to talk or have an interesting discussion. Hope to see you in Milan at the EACTS 2014.

On the other hand, when our surgery causes blood to leave the vascular system, blood becomes a highly toxic and injurious agent itself. When it intrudes our tissues and body cavities, blood causes a severe inflammatory response that can even be lethal to surrounding cells. Post-cardiac surgery, we try to evacuate all blood and clots from the pericardial space through chest tubes, only aided by gentle suction. In a considerable number of cases this method is only partial successful and very often variable amounts of blood and clots remain inside. Besides the chance of acute or late cardiac tamponade, blood can cause several inflammation related complications like adhesion formation. Isn’t it strange that we do not take the necessary and effective measurements to definitively clean up our operation site from this?